Metastatic ER+ breast cancer.
Conditions
Interventions
Trade Name: Cerianna
Product Name: 16a-18F-fluoro-17b-estradiol
Product Code: 16a-18F-fluoro-17b-estradiol
Pharmaceutical Form: Solution for injection
Sponsors
Amsterdam UMC - location VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven metastatic ER+ (>10% positive stained cells usingimmunohistochemistry) breast cancer on the latest biopsy - Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following: a. age =60 years b. age 12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists) c. patient age =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - History with another cancer within the last 5 years, except cancer treated with curative intent and no evidence of disease as judged by the treating physician. - Use of selective estrogen receptor modulators (SERMs) or downregulators (SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (=5 weeks prior to screening) or investigational drug therapy - Pregnancy or lactating women - Any medical, psychological or social condition that may interfere with the subject’s safety and participation in the study, will lead to exclusion from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - part A: to identify the pharmacokinetic model that represents the [18F]FES kinetics most optimally and to validate simplified quantitative parameters of [18F]FES uptake. - part B: to investigate the repeatability of simplified quantitative parameters of [18F]FES uptake. ;Secondary Objective: Not applicable.;Primary end point(s): - part A: the most optimal pharmacokinetic model (for instance the single tissue reversible, two tissue reversible or irreversible model) will be identified. Depending on the model, the most robust and stable parameter for quantification of tracer uptake in tumor lesions (for instance the net influx rate (Ki) or volume of distribution (VT)) will be correlated with standardized uptake values (SUVs) and tumor-to-blood ratios (TBRs). - part B: repeatability of simplified measures of [18F]FES uptake, i.e. SUVs and TBRs, will be assessed. ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated after the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All endpoints will be evaluated after the end of the study. ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated after the end of the study. | — |
Countries
Netherlands
Contacts
Public ContactTrial Office
Amsterdam UMC - location VUmc
Outcome results
None listed